Tractocile 7.5 mg/ml, solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tractocile 6.75 mg/0.9 ml solution for injection

atosiban

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tractocile is and what it is used for

2. What you need to know before you are given Tractocile

3. How Tractocile will be given to you

4. Possible side effects

5. How to store Tractocile

6. Contents of the pack and other information

1. What Tractocile is and what it is used for

Tractocile contains atosiban. Tractocile can be used to delay premature birth of your baby. Tractocile is used in pregnant adult women between week 24 and week 33 of pregnancy.

Tractocile works by reducing the strength of contractions in your uterus (womb). It also makes contractions occur less frequently. This occurs because the action of a natural hormone called "oxytocin", which contracts the uterus (womb), is blocked.

2. What you need to know before Tractocile is administered to you

Do not use Tractocile

• If you are pregnant for less than 24 weeks.

• If you are pregnant for more than 33 weeks.

• If your waters have broken (premature rupture of membranes) and you are at 30 weeks of pregnancy or more.

• If your baby (fetus) has an abnormal heartbeat.

• If you are experiencing vaginal bleeding and your doctor wants to initiate delivery so your baby is born immediately.

• If you have a condition called "severe pre-eclampsia" and your doctor wants to initiate delivery so your baby is born immediately. Severe pre-eclampsia is when you have very high blood pressure, fluid retention, and/or protein in your urine.

• If you have a condition called "eclampsia," which is similar to "severe pre-eclampsia" but also includes seizures. This means delivery must begin so your baby is born immediately.

• If your baby has died.

• If you have or may have an infection in the womb (uterus).

• If your placenta is blocking the birth canal.

• If your placenta is detaching from the wall of your womb.

• If you or your baby have other conditions that could be dangerous for continuing the pregnancy.

• If you are allergic to atosiban or to any of the other ingredients of this medicine (listed in section 6).

Do not use Tractocile if any of these situations apply to you. If you are unsure, inform your doctor, midwife, or pharmacist before Tractocile is administered to you.

Warnings and precautions

Talk to your doctor, midwife, or pharmacist before Tractocile is administered to you:

• If you think your waters have broken (premature rupture of membranes).
• If you have kidney or liver problems.
• If you are between 24 and 27 weeks pregnant.
• If you are carrying more than one baby.
• If you experience contractions again, treatment with Tractocile may be repeated up to three more times.
• If your baby is small for the duration of the pregnancy.
• If your uterus, after the baby is born, is unable to contract. This may cause bleeding.
• If you are carrying more than one baby and/or are taking medications that may delay your baby's birth, such as medications used for high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you have any of these conditions (or are unsure), inform your doctor, midwife, or pharmacist before Tractocile is administered to you.

Children and adolescents

Tractocile has not been studied in pregnant women under 18 years of age.

Use of Tractocile with other medicines:

Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and lactation

If you are pregnant and breastfeeding a baby, breastfeeding must be discontinued during treatment with Tractocile.

3. How Tractocile will be administered to you

Tractocile will be administered to you in a hospital by a doctor, nurse, or midwife. They will determine the amount you need. They will also ensure that the solution is clear and free from particles.

Tractocile will be administered intravenously in three stages:

• An initial intravenous injection of 6.75 mg in 0.9 ml will be given slowly into your vein over one minute.
• Then, a continuous infusion (drip) of 18 mg per hour will be administered for 3 hours.
• After that, a further continuous infusion (drip) of 6 mg per hour will be administered for up to 45 hours, or until your uterine contractions have stopped.

The total duration of treatment should not exceed 48 hours.

Additional courses of Tractocile may be given if your contractions return. Treatment with Tractocile may be repeated up to three more times.

During treatment with Tractocile, your contractions and the baby's heart rate may be monitored.

It is recommended not to repeat the treatment more than three times during one pregnancy.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects observed in mothers were generally mild in intensity. There are no known adverse effects on the fetus or newborn.

The following adverse effects may occur with this medicine:

Very common (affect more than 1 in 10 people)

• Feeling unwell (nausea).

Common (affect less than 1 in 10 people)

• Headache.
• Dizziness.
• Flushing.
• Being unwell (vomiting).
• Rapid heartbeat.
• Low blood pressure. Signs may include dizziness or feeling lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (affect less than 1 in 100 people)

• Increase in body temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

Rare (affect less than 1 in 1,000 people)

• Your uterus is unable to contract after the baby's birth. This may cause bleeding.
• Allergic reactions.

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lungs), particularly if you are pregnant with more than one baby and/or are being treated with other medicines that can delay your baby's birth, such as medicines used for high blood pressure.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tractocile

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (2°C – 8°C).

Keep in the original packaging to protect from light.

Once the vial has been opened, the product must be used immediately.

Do not use this medicine if you observe particles or discoloration of the contents before administration.

6. Contents of the container and other information

Composition of Tractocile

• The active substance is atosiban.
• Each vial of Tractocile 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
• The other components are mannitol, hydrochloric acid, and water for injections.

Appearance of Tractocile and contents of the container

Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution free from particles. One pack contains one vial with 0.9 ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ferring Pharmaceuticals A/S

Amager Strandvej 405
2770 Kastrup
Denmark

Tel: +45 88 33 88 34

Manufacturer:

Ferring GmbH

Wittland 11
D-24109 Kiel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this summary:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu.

This information is intended for healthcare professionals only:

(See also section 3).

Instructions for use:

Before using Tractocile, the solution should be examined to ensure it is clear and free from particles.

Tractocile is administered intravenously in three consecutive stages:

• An initial bolus injection of 6.75 mg in 0.9 ml is given slowly intravenously over one minute.
• A continuous infusion at a rate of 24 ml/hour is administered for 3 hours.
• A continuous infusion at a rate of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have decreased.

The total duration of treatment should not exceed 48 hours. Additional treatment cycles with Tractocile may be administered if contractions recur. Repeating the treatment more than three times during a single pregnancy is not recommended.